An Exploratory Clinical Study of Double Pig Tail Stent-assisted Fixation of Fully Covered Metal Stents for the Treatment of Benign Duodenal Strictures
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Clinical remission rate at 30 days post-operation
研究概览
简要总结
Double Pig Tail Stent-assisted Fixation of Fully-Covered Metal Stents for the Treatment of Benign Duodenal Strictures
详细描述
This study uses a double pig-tail stent for cross fixation of a fully-covered stent in the duodenum to reduce the incidence of displacement and ensure the stent can effectively expand the narrowed area, thereby alleviating patient symptoms.
The aim of this study is to explore the safety and efficacy of a double pig-tail stent-assisted fixation of a fully-covered stent for the treatment of benign duodenal strictures, further clarifying its long-term efficacy and providing strong support for the placement of fully-covered stents in treating benign duodenal strictures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subjects voluntarily signed the informed consent form for this trial;
- •Patients diagnosed with benign duodenal stricture;
- •Symptoms of upper gastrointestinal obstruction, such as nausea, vomiting, abdominal pain, or changes in bowel habits, occurring before admission or during hospitalization;
- •Patients with refractory strictures who have failed multiple balloon dilations;
- •Age < 75 years.
排除标准
- •Gastrointestinal perforation;
- •Distal small bowel obstruction or multiple segments of small bowel obstruction;
- •Coagulation disorders;
- •Strictures or obstructions caused by malignant tumors;
- •Severe comorbidities involving the heart, brain, lungs, kidneys, etc.
结局指标
主要结局
Clinical remission rate at 30 days post-operation
时间窗: at 30 days post-operation
Clinical remission: Symptoms of duodenal obstruction are relieved, and the postoperative GOOSS score improves by at least one grade compared to preoperative values.
次要结局
未报告次要终点
研究者
Shupei Li
student
Jinling Hospital, China